A Phase Ib/II Study of Ad-RTS-hIL-12 and Veledimex for Locally Advanced or Metastatic Breast Cancer

Full Title

A Single-arm, Open-label Study of Ad-RTS-hIL-12 + Veledimex Following First- or Second-Line Standard Treatment in Subjects with Locally Advanced or Metastatic Breast Cancer

Purpose

The purpose of this study is to assess the safety of a new type of immunotherapy in women who have already responded to one or two regimens of chemotherapy for locally advanced or metastatic breast cancer. The treatment consists of a genetically modified virus called Ad-RTS-hIL-12 given in combination with a drug called veledimex.

Together, Ad-RTS-hIL-12 and veledimex are designed to increase production of a protein called IL-12, which may strengthen the ability of the immune system to fight cancer cells and also decrease blood flow to tumors. The goal is to give patients a "holiday" from chemotherapy by focusing each person's immune system on the cancer.

Ad-RTS-hIL-12 is injected directly into the tumor once (after the patient has received local or general anesthesia). It is then activated by veledimex, a pill which is taken daily for seven days after the injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have experienced stabilization of the cancer or shrinkage of the tumor following at least 12 weeks of a prior chemotherapy regimen.

Patients may have had up to two prior regimens of treatment.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Stephen Solomon at 212-639-5012.